5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
FDA Recall Z-3087-2026 · Posted 2026-09-02
Advertisement
Recalling FirmFresenius Medical Care Renal Therapies Group, LLC
Recall StatusOpen, Classified
Product CodeKOC
Date Initiated2026-08-10
Product Quantity6,624 units
Reason for Recall
Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.
Firm Action
On 8/10/2026, the firm began notifying consignees via URGENT MEDICAL DEVICE RECALL letters.
Customers were instructed to
1. Identify any affected product on hand.
2. IMMEDIATELY segregate and discontinue use of affected lot.
3. Contact the call center at 1-888-943-4901 and reference Event 8514, between
8:00 AM 4:30 PM Eastern daily, for return of affected lots and replacement of your
stock.
4, Complete and return the included reply form.
Root Cause
Component change control
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement